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MRI And Cardiac-Rhythm Devices: A Match Made In Medicare

Executive Summary

A proposed coverage policy from the US Centers for Medicare and Medicaid Services would not only cover magnetic resonance imaging for patients with an implanted cardiac rhythm management device with an FDA-approved indication for MRI-compatibility, but will also cover MRI in patients with devices without that FDA labeling in certain circumstances.

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Medicare MRI Restrictions Removed For Cardiac Device Patients

The US Centers for Medicare and Medicaid Services followed through with a plan to expand its national coverage policy for MRI scans, removing contraindications and clinical-study requirements for patients with pacemakers, implantable cardioverter defibrillators and other cardiac rhythm devices.

Medicare Drops Registry Requirement In ICD Coverage Policy And Adds 'Shared Decision-Making'

The new Medicare coverage policy for implantable cardioverter defibrillators, the first revision since 2005, incorporates MRI-compatible devices, tweaks some of the patient criteria, removes thenational registry requirement, and adds a new requirement for "shared decision-making" prior to implanting an ICD in certain patients so the patients understand their options.

Market Advantage Of 'MR-Conditional' Device Labeling Fades

Abbott Laboratories and Boston Scientific recently logged approvals that bring the firms closer to parity with Medtronic in being able to market their cardiac rhythm management devices as compatible with MRI scans. But CMS, the US Medicare agency, is currently considering a coverage policy that make so-called "MR-conditional" product labeling less significant.

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